RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.

Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Other Names:

Paraplatin

Paraplatin-AQ

Drug: irinotecan

Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Other Names:

Camptosar®

Camptothecin-11

CPT-11

Detailed Description:

OBJECTIVES:

Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin.

Determine the median survival of patients treated with this regimen.

Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).

Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria:

Previously untreated metastatic or extensive disease

Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease

Fertile patients must use effective contraception during and for 3 months after completion of study treatment

No medical disease that, in the opinion of the investigator, would preclude study treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

At least 10 days since prior radiotherapy (including brain)

No prior irinotecan hydrochloride

At least 2 weeks since prior and no concurrent anticonvulsants

No concurrent radiotherapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387660